safety and tolerability study of the helical intravitreal triamcinolone implant in diabetic macular edema

Conditions: Diabetic Macular Edema

Summary: this phase 1 study will evaluate the safety, tolerability and duration of effect of a helical intravitreal triamcinolone implant for the treatment of diabetic macular edema over a three-year period.

the helical intravitreal triamcinolone implant is intended to provide sustained release of triamcinolone acetonide into the vitreous chamber of the eye.

Eligibility criteria:
inclusion criteria: * patients with clinically observable macular edema associated with diabetic retinopathy in study eye * macular edema in study eye is associated with 1. visual acuity of 20/40 or worse; and 2. retinal thickening in the fovea as seen on biomicroscopic examination 3. angiographic evidence of leakage involving the perifoveal capillary net * failure of macular edema to improve with prior macular photocoagulation, or the patient is unlikely to benefit from macular photocoagulation in the opinion of the investigator * patients must be 18 years of age and older * patients must be willing and able to return for scheduled follow up examinations for 3 years after initial surgery. * patients must sign and be given a copy of the written informed consent form. exclusion criteria: * monocular, or vision worse than 20/400 in the fellow eye * visual acuity worse than 20/200 20/200 and \< 34 letters read in the study eye * use of depot periocular steroids in the study eye within the past 30 days * current use of \>15 mg/day of oral steroids * known steroid responder * ocular hypertension \> 22 mmhg in the study eye or need for more than one medication to maintain iop \< 22 mmhg. * cup to disc ratio of \> 0.8 in the study eye * prior filtration surgery or glaucoma implant surgery in the study eye * any active ocular infection in either eye * history of herpetic ocular infection in the study eye * macular ischemia, defined as angiographic evidence of enlargement of the foveal avascular zone to 1 disc area or larger, centered on the fovea * macular or panretinal photocoagulation treatment in the study eye within the past 90 days; laser capsulotomy within the past 90 days * planned or known need for ocular surgery in the study eye within 90 days after enrollment and treatment * any condition that precludes the subject's ability to comply with study requirements, including examinations or the completion of the study; or any condition that precludes the examiner's ability to obtain reliable fundus photography, angiography, or oct images * females who are pregnant or lactating, and premenopausal females who are unwilling to use a medically accepted method of birth control for the duration of the study * participation in another investigational trial within 30 days prior to enrollment or during the study period * uncontrolled hypertension (systolic bp \> 160 mm hg and/or diastolic bp \> 90 mmhg) * uncontrolled diabetes (hba1c \> 13) * chronic renal failure requiring dialysis or anticipated renal transplant * retinal or choroidal neovascularization in the study eye; anticipated need for panretinal photocoagulation within the next 30 days * macular edema in the study eye known to be due to a cause other than diabetic retinopathy * use of immunosuppressant drugs

Keywords: dme